Team
René Wittwer
Project Manager with 20+ years in pharma IT, expert in PAS-X and system integration (ERP, LIMS, equipment connectivity), ensuring successful delivery of complex international projects.
Key Experiences
- Focus on modernizing pharmaceutical plants with digital systems like Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), Track & Trace systems, and IT/OT integration.
- Covered planning, execution, validation, and business process digitalization.
- Included system rollouts, upgrades, and integrations in drug substance and product production (e.g., PAS-X V3.3 implementation)
- Focused on enhancing operational efficiency, compliance, and process optimization
- Implemented serialization and aggregation solutions for regulatory compliance (e.g., Russian and EU serialization standards)
- Integrated packaging line systems with central Track & Trace systems
- Supported clients in selecting vendors for systems like LIMS and designing IT/OT integration concepts
- Focused on aligning technology solutions with business needs, as in global LIMS vendor selection
- Developed system templates, ERP integrations, and data historian solutions for enhanced data analytics and control
- Examples include Siemens PCS7 integration
- Comprehensive qualification of machines and systems according to GMP standards
- Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification
Technologies Used
MES
- PAS-X (V2.x-V3.x)
- TULIP
- Apprentice Tempo
LIMS
- Labware
- LabVantage
Track & Trace
- Optel
- Seidenader
- Uhlmann
- Laetus
Integration Tools
- Siemens PCS7
- Inmation Data Historian
- BOXI, Kepware
- SAP interaces (CPI, BTP)
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